Suture clip deployment devices

ABSTRACT

Suture clip deployment devices for applying suture clips to sutures are described. Some embodiments can include a generally tubular main body and a vacuum port located at the distal end, a hollow inner body longitudinally slidable within the main body and extending from the main body at its distal end, and a suture recess located in the generally tubular main body. At least one suture clip configured to frictionally fit on an outer surface of the inner body is deployed during use. Clip deployment can occur after a vacuum source is applied to the device so as to draw the suture into the device. The suture lines can be retrieved through the suture recess, and the device can be actuated so as to deliver the suture clip off the delivery device and onto the suture, locking the suture in place.

CROSS-REFERENCE TO RELATED APPLICATION

This application claims the benefit of U.S. Provisional Application No.61/579,497, filed Dec. 22, 2011, which is incorporated by referenceherein.

FIELD

This disclosure relates to devices and methods for securing suturesusing clips.

BACKGROUND

Sutures are used for a variety of surgical purposes, such asapproximation of tissue and ligation of tissue. When placing sutures,the strand of suture material to be used typically has a needle affixedto one end which is passed (looped) through the tissue to beapproximated or ligated, forming a stitch. The stitch is then tensionedappropriately, and the two free ends of the suture loop, the needle endand the non-needle end, are knotted to retain the desired tension in thestitch. Forming knots in suture during open surgery is a simple matter,though time-consuming, but forming knots in sutures during endoscopicsurgery can require two surgeons to cooperate in a multi-step processwhich is performed with multiple instruments to pass the needle andsuture back and forth to tie the suture knot.

Suture locking devices that eliminate the need to tie knots in order tospeed up heart valve replacement are known, as are suture lockingdevices in general. Suture retainers or locks are used in place ofsuture knots to prevent passage of a suture end into and through tissueand to maintain the tension applied to the suture material during thesuturing procedure.

When using a method that employs a clip to secure the suture, the clipcan be delivered by advancing the clip along a suture line to the areaof interest, and then deploying the clip such that the clip secures thesuture in place. With the clip thus secured, the excess suture can becut and removed from the patient. An example of such a clip as well asmethods and devices for use therewith are disclosed in U.S. Patent Pub.No. 2007/0005081 and U.S. Pat. No. 7,628,797, the entire contents ofwhich are expressly incorporated herein by reference.

Despite the existence of knotless suture locking devices in the art,there is a need for improved devices that enable easy access to thesuture, accurate tensioning of the suture and are simple to use. Inlight of the foregoing, there is presently a need for improved systemsfor securing sutures with clips.

SUMMARY

Disclosed herein are improved suture clip delivery devices and systemsthat are especially useful for securing heart valve repair orreplacement prostheses in or near the heart. The devices and methods areparticularly well suited for traditional surgery or minimally invasivesurgery. The devices disclosed herein can eliminate the need forsurgical knots thus reducing surgical time and exposure. Further, thedevices can improve the ease of implantation because the clinician neednot tie knots in the limited space in and around the heart.

Some embodiments of suture clip delivery systems described hereinutilize a suture clip having a generally tubular shape, with an innerlumen passing through the tube and a handheld vacuum-assisted device fordeploying the suture clips. The inner lumen of the device and clip issized and configured so that one or more lines of suture may passtherethrough. The clip has an open configuration wherein the inner lumenis generally unobstructed, and a closed configuration wherein the innerlumen is at least partially obstructed so that suture line(s) passingtherethrough are prevented from moving in one or more directions.

An exemplary system disclosed herein includes a device having agenerally tubular main body with a proximal end, a distal end, a vacuumport located at the distal end, a hollow inner body longitudinallyslidable within the main body and extending from the main body at itsdistal end, a suture recess located in the generally tubular main body,and at least one suture clip configured to frictionally fit on an outersurface of the inner body. The main body further comprises a mechanicaladvancer button and clip deployment occurs when the device ismechanically actuated via the mechanical advancer button. Multiple clipscan be loaded onto the inner body for deployment. The clips arepreferably made of a shape memory material.

Also disclosed herein is are methods for anchoring an implant to softtissue, the implant having been advanced to the soft tissue down aplurality of suture lines, comprising providing a delivery device havinga generally tubular main body with a proximal end, a distal end, avacuum port located at the distal end, an inner body longitudinallyslidable within the main body and extending from the main body at itsdistal end, a suture recess located in the generally tubular main body,and at least one suture clip configured to frictionally fit on an outersurface of the inner body; connecting a vacuum source to the vacuumport; approaching the suture lines with a distal end of the inner bodyof the device; applying a vacuum so as to draw the suture lines into thedistal end of the delivery device and through the main body; retrievingthe suture lines through the suture recess; adjusting tension in thesuture lines; and actuating the device so as to force the suture clipoff the inner body and onto the suture lines so as to lock the suturelines in place.

Some disclosed devices for deploying a suture clip onto a suturecomprise a proximal handle portion comprising an actuation mechanism anda generally tubular main shaft having an inner lumen, a proximal endportion coupled to the actuation mechanism, a distal end portion havinga distal opening in communication with the inner lumen, and anintermediate portion having a radial opening in communication with theinner lumen. The main shaft is configured to hold one or more annularsuture clips loaded on the distal end portion of the main shaft and themain shaft is also configured to receive at least one suture extendingthrough the distal opening, through the inner lumen, and through theradial opening. The device further comprises a pusher positioned atleast partially around the main shaft and coupled to the actuationmechanism independently of the main shaft. The pusher is configured tobe positioned proximal to the one or more suture clips when the one ormore suture clips are loaded on the main shaft. The actuation mechanismis configured to cause the main shaft to move proximally relative to thehandle portion, the pusher, and the one or more suture clips loaded onthe main shaft, such that a distal-most one of the one or more sutureslips slides distally off of a distal end of the main shaft and onto asuture extending through the distal opening of the main shaft.

In some embodiments, the inner lumen of the main shaft is fluidlycouplable to a vacuum source that reduce pressure within the inner lumensuch that a suture can be drawn into the inner lumen through the distalopening of the main shaft.

In some embodiment, the handle portion comprises a vacuum source that isfluidly coupled the inner lumen of the main shaft to assist in drawing asuture through the distal opening and into the inner lumen. The handleportion can further comprise a manual vacuum controller that controlsthe vacuum in the inner lumen.

In some embodiments, the device is configured such that, after a sutureclip is deployed onto the suture, the actuation mechanism causes themain shaft, the pusher, and any suture clips remaining on the main shaftto move distally together relative to the handle portion.

Some embodiments further comprise an outer shaft positioned around themain shaft and the pusher and coupled to the handle portion. The outershaft comprises a blade at a distal end portion that is configured tocut the suture after the suture clip is deployed onto the suture. Thecutting of the suture occurs between the distal end of the main shaftand a proximal end of the deployed suture.

In some embodiments, the actuation mechanism causes the outer shaft torotate relative to the main shaft and the handle portion, and whereinthe rotation of outer shaft causes the cutting of the suture.

Some embodiments further comprise a cover member slidably mounted overthe radial opening of the main shaft, the cover member being configuredto selectively open and close the radial opening of the main shaft.

In some embodiments, the pusher comprises a ratcheting mechanism thatallows the pusher to slide distally relative to the main shaft butprevents the pusher from sliding proximally relative to the main shaft.

In some embodiments, the device is configured to be loaded with aplurality of suture clips that are deployable without reloading thedevice.

Some embodiments further comprise a suture tension monitoring systemconfigured to determine and display the amount of tension in a suturepositioned within the inner lumen of the main shaft.

Some embodiments further comprise a suture clip monitoring systemconfigured to determine and display the number of suture clips that arecurrently loaded on the main shaft.

Some embodiments further comprise a lighting system configured toprovide light near the distal end of the main shaft. The lighting systemcan comprise one or more light fibers that extend along the length ofthe main shaft and are configured to conduct light from a proximal lightsource to near the distal end of the main shaft.

Some embodiments further comprise a visual monitoring system configuredto capture visual information from the near the distal end of the mainshaft and transfer the captured visual information to a proximal visualdisplay.

In some embodiments, the one or more suture clips are comprised of ashape-memory material, wherein the one or more suture clips are held ina resiliently deformed annular configuration when loaded onto the mainshaft, and wherein the one or more suture clips resiliently returntoward a natural collapsed configuration when deployed onto the suture,thereby becoming frictionally secured to the suture.

An exemplary method for deploying a suture clip onto a suture comprisescausing a free end of at least one suture to enter into a distal endportion of an inner lumen of a main shaft of a suture clip deploymentdevice, and then causing the main shaft to move proximally relative to asuture clip mounted around an outer surface of the main shaft such thatthe suture clip slides distally off of a distal end of the main shaftand onto the at least one suture such that the suture clip resilientlysecures to the suture.

In some methods, inserting a free end of the suture into the distal endportion of the inner lumen comprises reducing the air pressure withinthe inner lumen in order to draw the free end of the suture into theinner lumen.

In some methods, inserting a free end of the suture into the a distalend portion of the inner lumen comprises drawing the free end of thesuture out of the inner lumen through a lateral opening in the mainshaft.

Some methods further include applying tension to the free end of thesuture projecting from the lateral opening.

Some methods further include causing a blade of the suture clipdeployment device to cut off the free end of the suture after the sutureclip is secured to the suture. Such methods can further include, afterthe suture is cut, causing the main shaft and suture clips remainingmounted on the main shaft to move distally relative to a handle portionof the suture clip deployment device. After the main shaft and sutureclips remaining mounted on the main shaft to move distally relative to ahandle portion, the method can include repeating process to deployanother suture clip onto another suture.

A further understanding of the features and advantages of the presentinvention will become apparent from a consideration of the followingdetailed description.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 depicts a perspective view of a vacuum-assisted suture clipdelivery device as described herein.

FIGS. 2A and 2B show perspective views of the distal portion of thedevice of FIG. 1.

FIGS. 3A, 3B, 3C, and 3D depict side, top, perspective, and distal endviews, respectively, of a suture clip in an open configuration accordingto an embodiment of the invention.

FIG. 4 depicts a side view of a suture clip in a closed configurationwith a length of suture running therethrough according to an embodimentof the invention.

FIGS. 5A-5C depict side views of the most distal portion of the deliverydevice showing suture clip deployment according to an embodiment of theinvention.

FIGS. 6A and 6B illustrate the device of FIG. 1 advanced within apatient's body and being utilized to secure an artificial heart valve toexisting heart tissue according to an embodiment of the invention.

FIGS. 7A-7F depict side (solid), side (cross section), top, bottom,perspective, and end views, respectively, of a suture clip in an openconfiguration according to an embodiment of the invention.

FIGS. 8A-8E depict side (solid), side (cross section), top, bottom, andperspective views, respectively, of the suture clip of FIGS. 7A-7F in aclosed configuration.

FIG. 9 depicts a side view, in cross section, of a suture clip accordingto an embodiment of the invention.

FIG. 10 depicts a plan view of a cut-out pattern for a suture clipaccording to an embodiment of the invention.

FIG. 11A-11C depict side views, in cross-section, of suture clipsaccording to various embodiments of the invention.

FIGS. 12A-12C depict side views, in cross-section, of suture clipsaccording to various embodiments of the invention.

FIGS. 13A and 13B depict cross-sectional side and end views,respectively, of a suture clip in an open configuration according to anembodiment of the invention.

FIGS. 14A and 14B depict cross-sectional side and end views,respectively, of the suture clip of FIGS. 13A and 13B in a bent (closed)configuration.

FIGS. 15A and 15B depict cross-sectional side and end views,respectively, of a suture clip in an open configuration according to anembodiment of the invention.

FIGS. 16A and 16B depict cross-sectional side and end views,respectively, of the suture clip of FIGS. 15A and 15B in a bent (closed)configuration.

FIG. 17A is a perspective view of another exemplary suture clipdeployment device.

FIG. 17B is a perspective view of a shaft portion of the device of FIG.17A.

FIG. 18A is an exploded view of the shaft portion of the device of FIG.17A.

FIGS. 18B-18F are enlarged views of portions of FIG. 18A.

FIG. 19A is an exploded view of a handle portion of the device of FIG.17A.

FIGS. 19B and 19C are enlarged views of portions of FIG. 19A.

FIG. 21 is a side view of the device of FIG. 17A.

FIG. 22 is a top view of the device of FIG. 17A.

FIG. 23A is a cross-sectional view of the device of FIG. 21 taken alongsection line B-B of FIG. 21.

FIGS. 23B-23F are enlarged views of portions of FIG. 23A.

FIG. 24 is a side view of the handle portion of the device of FIG. 17Awith a portion of the housing removed.

FIG. 25 is a side view of the handle portion of an alternativeembodiment of the device of FIG. 17A with a portion of the housingremoved.

FIG. 26 is schematic top view of another exemplary suture deploymentdevice that includes a lighting system and a visual monitoring system.

FIG. 27 is a cross-sectional view of a shaft portion of the device ofFIG. 26 taken along section line 27-27.

DETAILED DESCRIPTION

Described herein devices and methods for securing sutures with sutureclips. FIG. 1 depicts a suture clip delivery device 10 according to oneembodiment. The handheld suture clip delivery device 10 has a generallytubular main device body 12 having a proximal end 14 and a distal end16. The proximal end 14 includes a vacuum port 80 and a suture recess82. The distal end 16 includes a mechanical advancer button 84.Extending past the distal end 16 of the device is an inner body 26,shown here having multiple suture clips 20 positioned thereon. The innerbody 26 is longitudinally slidably positioned within the main body 12 ofthe delivery device. The inner body 26 includes a distal end 28 whichextends distally out of the main body distal opening 24. The vacuum port80 located at the proximal end 14 of the device 12 is configured to beattached to a vacuum source (not shown). When the user attaches thevacuum port 80 to any vacuum source, suction is created within thedevice 10. The suction assists the user in drawing the suture lines intothe distal end 28 of the inner body 26 thereby threading the suturesthrough the device. The suture lines exit the device 10 at the suturerecess 82. It should be noted that the suture clip delivery device 10can be manufactured in a variety of shapes, sizes, lengths, widths, andbiologically-compatible materials as desired for a particularapplication.

The device 10 and the inner body 26 both feature at least one lumen toallow passage of a suture therethrough as well as to allow for suctionvia the vacuum port 80. Some embodiments may include more than one lumenwithin the device 10. For example, one lumen may extend from the distalend 28 of the inner body 26 to the vacuum port 80, and another separatelumen may extend from the distal end 28 of the inner body 26 to thesuture recess 82. In either case, suction is used to draw the sutureinto the device 10; the ends of the sutures exit the device 10 via thesuture recess 82 which enables the user to tension the sutures prior toclip deployment.

FIGS. 2A and 2B illustrate the distal portion of the suture clipdelivery device 10. As shown, multiple clips 20 are loaded onto theouter surface of inner body 26 and are held onto the inner body 26 by afriction fit, thus preventing the clips 20 from inadvertently fallingoff the distal end 16 of the device 10 prior to deployment. The innerbody 26 is slidably coupled within the main body of the device 12 toallow at least partial retraction of the inner body 26 into the distalend 16 of the device 10. FIG. 2A specifically shows the position of theinner body 26 relative to the clips 20 and distal end 16 of the device10 prior to actuation using the mechanical advancer button 84. FIG. 2Bshows the position of the inner body 26 relative to the clips 20 anddistal end 16 of the device 10 after actuation. Actuation of thedelivery device 10 using the advancer button 84 will be described inmore detail below.

As can be seen in FIGS. 2A and 2B, the inner body 26 of the deliverydevice 10 is slidably positioned within main device body 12. A sutureclip 20 is positioned on the inner body distal end 28, which protrudesfrom the main body distal opening 24. As depicted in FIG. 2B, the sutureclip 20 is placed on inner member distal end 28 in its openconfiguration wherein the clip body is generally straight (i.e.,unbent). The suture clip 20 is secured to the inner body distal end 28by means of the frictional engagement of the clip body against the outersurface of inner body 26.

Note that a clip according to this particular invention may have a(relatively gentle) curve along its length but still be considered“generally straight.” The term “generally straight” is used to refer toa configuration wherein the clip does not have a relatively tight bendsufficient to cause crimping of the inner lumen.

FIGS. 3A through 3D illustrate a suture clip 20 in an “open”configuration, while FIG. 4 depicts the suture clip 20 in a “closed” or“locked” configuration. The suture clip 20 can be manufactured from avariety of materials including, for example, nickel-titanium alloys,shape-memory alloys, stainless steel, titanium, various plastics, andother biologically-compatible materials. Suture clip 20 has a generallytubular body 44 and an outer wall 46, and includes a distal opening 50leading to an internal attachment lumen 48 extending axially through thesuture clip 20 to a proximal opening 52. The suture clip 20 includes oneor more engagement tab(s) 54 a, 54 b formed in the suture clip 20 andconfigured to leave the inner lumen relatively unobstructed when in the“open” configuration as depicted in FIGS. 3A-3D, and to at leastpartially obstruct the inner lumen 48 when in a “closed” configuration,as depicted in FIG. 4. The suture clip 20 includes notches 53 a, 53 bformed adjacent the tabs 54 a, 54 b, with the notches 53 a, 53 b helpingto create a hinge-point 55 about which the proximal half 57 a and distalhalf 57 b of the clip body 44 can bend.

The clip body 44, distal opening 50, proximal opening 52, inner lumen48, and engagement tabs 54 a, 54 b are sized and configured (when theclip body 44 and engagement tabs 54 a, 54 b are in the “open”configuration as shown in FIGS. 3A-3D) to slidingly receive one or moresuture leads therethrough. Prior to deployment, the clip body 44 is inits open (i.e., straightened) configuration, and the engagement tabs 54a, 54 b are moved to their “open” configuration by being deflectedradially out of the inner lumen 48 such that the engagement tabs 54 a,54 b are essentially flush with the suture clip outer wall 46, therebyleaving the inner lumen 48 essentially unobstructed, or at leastunobstructed to the extent necessary for the suture lines to slidinglypass within the lumen 48. As depicted in FIG. 3A, the inner lumen 48(with the clip body 44 straightened and the engagement tabs 54 a, 54 bin their open configuration) provides a relatively large andunobstructed passage sufficient to permit suture leads to slidetherethrough.

Upon deployment, i.e. after the suture leads have been retracted throughthe delivery device by means of a vacuum applied to the device, andtightened to their desired position, the suture clip 20 is advanced toits desired deployment position and forced off the end of the deliverydevice. The clip body 44 is bent (which may include stressing aplastically deformable clip to assume the bent configuration, orpermitting a biased clip to spring back to the bent configuration), withclip bending occurring along a hinge point 55. The engagement tabs 54 a,54 b are deflected or permitted to spring back into the inner lumen 48toward the hinge point 55 such that the inner lumen 48 is at leastpartially blocked, as depicted in FIG. 4. Suture lines 56 a, 56 b areheld fast within the closed clip 20, with the engagement tabs 54 a, 54 bengaging against and securing the suture lines 56 a, 56 b against theclip body 44. The “closed” engagement tabs 54 a, 54 b and bent clip body44 cause the suture lines 56 a, 56 b passing therethrough to adopt a“serpentine” path through the clip inner lumen 48. This serpentine path,combined with the friction on the suture from the clip body 44 andengagement tabs 54 a, 54 b, serves to lock the suture 56 a, 56 b inplace and prevent longitudinal movement thereof within the clip lumen48. The suture 56 a, 56 b is thus held secure by the combination of tab54 a, 54 b to clip inner wall interaction/forces and by the tortuouspath that the bent clip body 44 and tabs 54 a, 54 b force the suturelines 56 a, 56 b to follow, which provides more surface area contactwith the suture 56 a, 56 b to increase retention. Note also that thebending of the clip body 44 holds the tabs 54 a, 54 b against eachother, so that neither of the tabs 54 a, 54 b can bend back outwardlywithout engaging against the other tab.

As shown in FIG. 4, the suture lines 56 a, 56 b are relatively thin ascompared to the clip lumen 48. However, depending on the particularapplication, suture that is of a much greater thickness can be used witha clip according to the invention. If used with thicker suture(s), aclip 20, and particularly the tabs 54 a, 54 b, might assume a somewhatdifferent shape once deployed. With a thicker suture line or lines, thetabs 54 a, 54 b would each be forced back outward (i.e., toward their“open” configuration”) by the suture, but the bending of the clip body44 and the resulting interaction between the tabs 54 a, 54 b willprevent excessive tab movement, and the suture will still be heldsecurely within the clip body 44.

Depending on the particular embodiment, including the materials fromwhich a particular suture clip is made, the clip body (and the bendtherein) as well as the engagement tab(s) may be biased to spring towarda desired position, which may be either the closed configuration or theopen configuration, depending on the particular application.

FIGS. 5A-5C depict, in various configurations, deployment of a clip 20from the distal end 16 of the suture clip delivery device 10 accordingto an embodiment of the invention. FIG. 5A depicts the device inner bodydistal end 28 extending from device main body distal opening 24, with asuture clip 20 positioned on the inner body distal end 28. A suture line56 extends through material or tissue portions 58 a, 58 b and vacuum isused to draw the suture line into the distal end of the device. In theparticular embodiment depicted, the clip 20 is biased towards its closedconfiguration, and the inner body distal end 28 of the device 10physically holds the clip 20 in its open configuration. Suture 56extends from the suture clip 20, with suture leads 56 a and 56 bextending through the clip inner lumen 48 via the clip distal opening50, engagement tab 54, and proximal opening 52. By virtue of the vacuum,the suture leads 56 a, 56 b pass through device inner member distalopening 30 and inner member lumen 32, exiting the inner member 26 of thedevice via suture recess 82, and exiting the side of main body 12 (notshown). The user is then able to manually adjust the tension in thesuture prior to securing the suture in place.

Clip deployment occurs when the device 10 is mechanically actuated bythe user via the mechanical advancer button 84. In one embodiment, thebutton 84 is depressed causing the inner body 26 to be at leastpartially retracted within the device 10. During actuation, as shown inFIGS. 2A-B, the inner body 26 begins to move proximally toward thedistal end 16 of the device 10. With this action, the length of theinner body 28 outside of the device 10 is decreased and the proximal endof the most proximal clip 20 abuts the distal end 16 of the device 10forcing the most distal clip 20 to edge off of the distal end 28 of theinner body 26. Once the clip 20 is completely off of the inner body 28and strung onto suture 56, the clip assumes its “closed position” asdescribed above with reference to FIG. 4 and locks the suture in place.The user then withdraws the suture clip device 10 from the patient,leaving the suture 56 and suture clip 20 in place in the desired tissue.

The device inner body distal end 28 retracts into the main body distalopening 24 by manipulation of the mechanical advancer button 84. Withthe inner body distal end 28 retracted, the suture clip 20 is releasedfrom the device 10, as shown in FIG. 5B. As the inner body distal end 28is retracted, the suture clip 20 is engaged against the distal edge 25of the main body distal opening 24 and is forced off of the inner bodydistal end 28 at a position adjacent the material portions 58 a, 58 b.With the suture clip 20 freed from the device, the clip 20 assumes itsclosed (i.e., bent) configuration, with the clip body 44 bent and theengagement tabs 54 a, 54 b projecting inward to at least partiallyobstruct or even to completely close the clip inner lumen 48 whileengaging the suture lines 56 a, 56 b. With the suture clip 20 in thisclosed configuration, the suture lines 56 a, 56 b are held fast andcannot move longitudinally within the suture clip 20. The suture lines56 a, 56 b are thus held by the combination of tab to inner wallinteraction/forces and by the tortuous path that the tabs 54 a, 54 b andbent clip body 44 force the suture lines 56 a, 56 b to follow, whichprovides more surface area contact with the suture lines 56 a, 56 b toincrease retention. Note that the suture lines 56 a, 56 b still passinto the device 10, exiting the inner body 26 via suture recess 82 andexiting the side of main body 12 through suture recess 82. FIG. 5Cdepicts the device inner body 26 retracted even further within thedevice main body 12.

FIGS. 6A and 6B illustrate a particular use for the device 10 to securewith a clip sutures used to attach two layers together, wherein onelayer is a cardiac implant 78, such as an artificial valve implant andthe other is a heart valve annulus. In the embodiment depicted, thesuture 56 has previously been passed through the desired materialstructures within the patient's body. After suturing the implant 78 tothe heart tissue 88 with suture 56, the user approaches the suture lineswith the distal end 28 of the inner body 26 of the device 10. Vacuum isapplied to the device; in some cases, the user covers the suture recess82 with his finger to enable suction throughout the length of thedevice. With the vacuum source connected to the vacuum port 80, negativepressure is created within the inner body 26 of the device along itslength from the vacuum port 80 to the distal end 28. The suture lines 56are drawn into the distal end 28 of the inner body 26 and through thedevice 10, exiting the device 10 at the suture recess 82. The user canthen adjust the tension in the suture 56 using the portions of thesuture that are outside the device 10. The user can verify theeffectiveness of the tightened suture 56 by monitoring various patientfunctions. For example, the user may confirm the result by monitoringblood flow using radiopaque dyes combined with fluoroscopy. If the useris dissatisfied with the results when the suture 56 is initiallytightened, the user can remove the suture 56 entirely from the patient'sbody and repeat the suture deployment to try to achieve a betterpositioning of suture. If, however, the user is satisfied with theresults, the user deploys the suture clip 20 from the device 10.

Referring still to FIGS. 6A and 6B, after placement of the suture at thedesired location and achieving the desired tension, the suture clip 20is deployed from the delivery device 10. The suture clip 20 is releasedfrom the distal end of the device 10, securely holding the suture 56 inplace. The user can then cut the free end(s) of the suture 56 and removeany excess suture by simply pulling the excess suture out of thepatient's body. The user then withdraws the suture clip device 10 fromthe patient, leaving the suture 56 and suture clip 20 in place.

Note that the number, shape, and configuration of the engagement tabsand hinge points on a particular clip can vary, depending on theparticular application. For example, the engagement tabs can bepositioned on opposing sides of the clip, on the same side of the clip,in a spiral pattern about the clip body, etc. Similarly, the hingepoints can be positioned on opposing sides of the clip, on the same sideof the clip, in a spiral pattern, etc.

Various methods and/or systems can be used to pass the suture throughthe desired material, as is well known in the art. Moreover, althoughFIGS. 6A and 6B depict the device used to replace a heart valve, thedevice can also be used in other procedures, including materialtreatments such as so-called “edge-to-edge” mitral valve repairsinvolving edge-to-edge suturing of adjacent mitral valve leaflets.Embodiments of the system may be used to occlude a left atrial appendagefor decreasing the risk of arterial embolism, for example. In anotherprocedure, material along the ostium of the left atrial appendage issutured together to prevent blood from flowing in and out. Thisprocedure is preferably performed using a transeptal approach and may beperformed after delivering an expandable device into the left atrialappendage for filling the volume and further preventing the formation ofthrombus. In another method of use, the system may be used for occludingfallopian tubes in a minimally-invasive sterilization technique. In thisprocedure, the system is advanced into a fallopian tube and suture isapplied to pull opposing walls together, thereby blocking the tube. Instill other applications, the system may be used to treat organprolapse, such as uterine or bladder prolapse. This procedure may beused to pull tissue together in a percutaneous procedure to treatprolapse by providing additional support at locations wherein musclesand/or ligaments have become stretched or have been otherwise damaged.

Additional information on procedures for which the surgical clipdelivery device can be useful are disclosed in the following references,the entire contents of which are expressly incorporated herein byreference: U.S. Pat. No. 6,626,930 issued to Allen et al.; U.S. patentapplication Ser. No. 10/106,583, filed Mar. 26, 2002 and entitled,“Sequential Heart Valve Leaflet Repair Device and Method of Use”; U.S.patent application Ser. No. 10/233,879, filed Sep. 3, 2002 and entitled“Single Catheter Mitral Valve Repair Device and Method”; U.S. patentapplication Ser. No. 10/389,721, filed Mar. 14, 2003 and entitled“Mitral Valve Repair System and Method of Use”; and U.S. patentapplication Ser. No. 11/174,143, filed Jun. 30, 2005 and entitled“System, Apparatus, and Method for Repairing Septal Defects.”

FIGS. 7A-7F and 8A-8E depict, in open and closed configurations,respectively, additional clip configurations. The suture clip 20 isinitially formed from a generally tubular body 44, such as a portion ofnitinol hypotube into which the desired pattern of tabs 54 a, 54 b, tabstress cutout windows 66, bending notches 53, and stress-relief cuts 68,etc., is formed.

Note that the clip 20 including the pattern of tabs 54 a, 54 b, etc.,can be formed in various ways, depending on the particular application.For example, injection molding, die and coining, laser cutting,machining, and shape setting can be used, alone or in combination,depending on the particular clip configuration and materials. In oneembodiment, the pattern is formed by laser cutting the desired patterninto a portion of a hypotube or other generally tubular body. FIGS.7A-7F depict the generally tubular body 44 after the desired pattern hasbeen cut into the generally tubular body, but before the tubular bodyhas been bent and before the tabs 54 a, 54 b have been bent or otherwisemoved and set into position to block the inner lumen 48. Theconfiguration depicted in FIGS. 7A-7F also corresponds with the “open”configuration of the clip 20.

FIGS. 8A-8E depict the clip 20 of FIGS. 7A-7F, but with the clip body 44bent and the tabs 54 a, 54 b bent into and set in their “closed”position, wherein the inner lumen 48 is at least partially blocked. Thenotches 53 on either side of the clip 20 create a hinge point 55 aboutwhich the clip 20 can easily bend. (Note that, although the term “hingepoint” is used herein, the actual bending may occur over a relativelylarge area, as is shown in the embodiment of FIGS. 8A-8E.) The tabstress cutout windows 66 enhance the flexibility while maintainingstrength of the tabs 54 a, 54 b, and also reduce stress on thehinge-like portion where each tab 54 a, 54 b connects to the generallytubular body 44 of the clip 20. The stress relief lines 68, which are onthe same side of the clip 20 as the hinge point 55, help to relievestress that might build up on that side of the clip body 44 as the clip20 assumes its bent configuration. In the embodiment of FIGS. 8A-8E, thefree ends of the engagement tabs 54 a, 54 b are directed toward eachother, and are both on an opposite side of the clip body 44 from thehinge point 55.

FIG. 9 depicts, in cross section, a side view of a further embodiment ofa clip 20. The clip 20 includes a single tab 54 positioned across from ahinge point 55. The clip 20 includes a beveled inner edge 70 at one ormore of the clip openings, such as the clip distal opening 50 asdepicted. The beveled inner edge 70, which in the embodiment depicted isat an angle of about 45 degrees, can assist in threading suture into theclip 20 through the clip distal opening 50. The clip 20 can also includeone or more generally semi-circular openings 72 at one or more openingssuch as the clip proximal opening 52. The semi-circular openings 72 canaid in processing of the clip during manufacture, e.g., permitting easyalignment and holding of the clip 20 during bending and/or shape settingof the clip body 44 and tabs 54 a, 54 b, etc. After clip manufacturingis complete, the semi-circular openings 72 can interact withcorresponding structure on the device distal end to assist in alignmentand positioning of the clip 20 on the device distal end.

The clip 20 depicted in FIG. 9 also includes a window-like opening 74aligned opposite to the free edge of the tab 54, positioned so that whenthe tab 54 extends into the inner lumen 48 the free edge of the tab 54can rest within the window-like opening 74, but without extending out ofthe clip 20 itself. The window-like opening 74 permits tab 54 to be bentor otherwise positioned so that the tab free edge extends across andjust beyond the inner lumen 48, thereby compensating for any backwardtab movement (either through material recovery or outward pressure fromthe suture lines, etc.) that might occur after the tab 20 is initiallydeployed to its closed configuration. Note that a window-like openingsuch as element 74 from FIG. 9 could be positioned at or near a hingepoint, so that the window-like opening serves multiple purposes:receiving the tab free edge, relieving stress that might developadjacent the hinge point, and providing for relatively easy bending orflexing of the clip body about the hinge point.

FIG. 10 depicts a cutout pattern (in flattened or unrolledconfiguration) for creating the suture clips. The generallyelliptically-shaped portion 76 of each the tabs 54 a, 54 b (with 54 bhaving a dashed portion depicting an imaginary completion of the“ellipse” that forms the actual tab) has a width W (i.e., minor axis)that is approximately equal to (but still slightly less than) thediameter of the clip inner lumen 48. The generally elliptical shapedportion 76 has a length L (i.e., major axis) that is greater than thediameter of the clip inner lumen 48. These dimensions permit each tab 54a, 54 b, when in the closed configuration, to fit within the clip innerlumen 48 and still close off essentially the entire diameter of the clipinner lumen 48, thereby securely holding any suture passingtherethrough.

Note that because the pattern of tabs and windows may have been cut in aradial manner into the generally tubular body 44 of the clip 20, thetabs 54 a, 54 b each have an inner surface having an “inner”elliptically-shaped portion that is somewhat smaller in width than itscorresponding “outer” elliptically-shaped portion 76 discussed above.Accordingly, the relatively narrow width of each tab's respective innerelliptically-shaped portion may only partially obstruct the inner lumen48. However, the tab outer surface has the full width W of theelliptically-shaped portion 76 shown in FIG. 10, and it is this width(W) of the “outer” elliptically-shaped portion 76 that obstructs theremaining diameter of the inner lumen 48 when a tab 54 a, 54 b extendsinto the inner lumen 48.

The dimensions of the clip can vary depending on the particularapplication. In one embodiment, a clip 20 such as that depicted in FIGS.7A-7F has a length of about 0.13 inches, an inner lumen diameter ofabout 0.030 inches, and an outer diameter of about 0.046 inches. A clipof this size can receive and secure multiple suture lines having variousdiameters, including sutures having diameters ranging from 0.006 to0.008 inches. Other clip dimensions are also within the scope of theinvention, with the clip dimensions varying depending on aspects of theparticular application, e.g., suture type and diameter, the type ofmaterial to be repaired, the number of suture lines being secured by theclip, etc. Additionally, although the particular embodiments depictedhave used the clip to secure two suture lines, the clip could be used tosecure a single suture line or multiple suture lines. For multiplesuture lines, two or more of the multiple suture lines could be portionsof a common suture line. For example, a clip could be used to securefour suture lines, with two of those suture lines being opposingportions of a first common suture line and the other two suture linesbeing opposing portions of a second common suture line. Note that theembodiments depicted are only a few examples of many that are within thescope of the invention. Depending on the particular embodiment, the taband other cut-outs could be formed in various shapes, and they could bealigned in a common direction with other cutouts, be in oppositedirections of alignment, and/or could be positioned in variousdirections along the clip outer wall.

FIGS. 11A-11C depict in cross-section an engagement tab 54 in variousconfigurations. In the embodiment of FIG. 11A, the engagement tab 54 isgenerally aligned with the clip outer wall 46, so that the clip innerlumen 48 is generally unobstructed. In FIG. 11B the engagement tab 54 ispositioned to extend partially into the lumen 48, with the angle 80between the engagement tab 54 and adjacent portion of the clip outerwall 46 being on the order of 45 degrees. FIG. 11C depicts theengagement tab 54 extending to a maximum extent into the clip lumen 48,with the angle 80 between the engagement tab 54 and adjacent portion ofthe clip outer wall 46 being on the order of 90 degrees. Note thatvarious angles 80 are within the scope of the invention, depending onthe particular embodiment and such factors as the size of the suture,the size of the clip, the percentage of the inner lumen that is desiredto be obstructed, the length of the engagement tab with respect to theinner diameter of the lumen, the bend added to the clip body 44, etc.

FIGS. 12A-12C depict clips 20 having various lengths 82 of engagementtabs 54. Although the embodiments of FIGS. 12A-12C are all depicted ashaving an angle 80 of about 90 degrees, it is noted that other anglesare within the scope of the invention, as discussed above with respectto FIGS. 11A-11C. In FIG. 12A, the engagement tab 54A has a length 82Aequal to about 50% of the clip inner lumen diameter 84. In FIG. 12B, theengagement tab 54 b has a length 82 b of about 75% of the clip innerlumen diameter 84, while in FIG. 12C the engagement tab 54 c has alength 82 c of about 100% of the clip inner lumen diameter 84. Notethat, as with the angle 80, the engagement tab length 82 for aparticular clip can vary depending on the particular application andstill fall within the scope of the invention.

Note that the bending of the clip body 44 itself can effectively block aclip inner lumen, with or without engagement tabs such as those (54, 54b, 54 c) depicted in FIGS. 12A-12C, etc. FIGS. 13A-13B and 14A-14Bdepict a clip 20 having a hinge point 55, but without tabs or otherprojections inside the inner lumen 48. In FIGS. 13A-13B, the clip body44 is in its straight or open configuration, without any bending aboutthe hinge point 55. The inner lumen 48 is seen in FIG. 13B as beingessentially open and unobstructed adjacent the hinge point 55. In FIGS.14A-14B, the clip 20 is in its bent or closed configuration, with arelatively sharp bend in the clip body 44 adjacent the hinge point 55.The inner lumen 48 is seen in FIG. 14B as being almost entirely blockedadjacent the hinge point 55. Note that although a single hinge point 55and associated bend is depicted in FIGS. 14A-14B, a suture clipaccording to the invention could include multiple hinge points andassociated bends along the length of the suture clip.

FIGS. 15A-15B and 16A-16B depict a clip having a hinge point 55 withinward-facing obstructions in the form of inner bumps 86 that extendinto the clip inner lumen 48 at or adjacent the hinge point 55. In FIGS.15A-15B, the clip 20 is in the open configuration, with the inner lumen48 being generally unobstructed adjacent the hinge point 55 except forminimal areas covered by the inner bumps 84, as depicted in FIG. 15B, sothat the inner lumen 48 has a size sufficient for suture to slidinglypass therethrough. FIGS. 16A-16B depict the same clip 20 in its closedconfiguration, wherein the clip body 44 is bent and has an almostflattened shape adjacent the hinge point 55, as depicted in FIG. 16B.With the bumps 86 engaging against each other and/or the clip wall, theinner lumen 48 is generally obstructed adjacent the hinge point 55 sothat suture lying within the inner lumen 48 will be held fast.

Clips can be formed from various biocompatible materials, includingshape memory and/or pseudoelastic materials such as nitinol. In oneembodiment a suture clip is formed from nitinol (such as an alloy ofnickel at 54.5-57% by weight with titanium accounting for the balanceexcept for residual amounts (less than 0.05% each) of oxygen, carbon,and hydrogen) or another shape memory and/or pseudoelastic material,with the suture clip formed so that the clip assumes its closed position(i.e., with the clip body in the bent configuration and the clipengagement tabs extending into the clip inner lumen) when in theaustenite condition (i.e., when generally unstressed at bodytemperature). The nitinol can have an austenite finish temperatureselected to match the particular application. In a medical suture clip,an austenite finish temperature of −5 degrees to +15 degrees Celsius maybe selected.

A suture clip can be formed from material that will assume itsmartensite condition when subjected to sufficient stress, such as thestress applied to the clip engagement tabs 54 and clip body 44 when thesuture clip 20 is mounted onto the device inner body distal end 28, asdepicted in FIG. 5A. In such an embodiment, the device inner body distalend 28 applies stress to the clip body 44 and clip engagement tabs 54,forcing the clip body 44 to be straight and the clip engagement tabs 54into general alignment with the clip outer wall 46. The stressedmaterial, including the bent material where the clip engagement tabs 54meet the rest of the clip outer wall 46, is forced into its martensitecondition. Then the stress is removed, such as where the suture clip 20is removed from the device 10 and device inner body distal end 28 asdepicted in FIGS. 5B and 5C, the material returns to its austenitecondition so that the clip body 44 assumes its bent shape and the clipengagement tabs 54 are biased inwardly to at least partially block theclip inner lumen 48.

FIGS. 17-25 illustrate an exemplary suture clip deployment device 100.The device 100 can be loaded with one or more suture clips and can beused to deploy the suture clips onto sutures, such as duringimplantation of prosthetic device within the heart. The device 100comprises a handle portion 102 that can be held and actuated by a userand a shaft portion 104 that can be inserted into the body, at leastpartially, to deploy suture clips onto sutures in hard to reach regionswithin the body in a minimally invasive manner. The device 100 can beused with any of the suture clips described herein or their equivalents,which are collectively referred to with the reference number 130 below.FIG. 17A shows the device 100 with exemplary sutures 131 inserted intothe distal end of the device. FIG. 17B shows the shaft portion 104 ofthe device 100 with a suture 131 passing through an inner lumen of thedevice 100 with a free end of the suture projecting out through alateral opening in the device, as describe in more detail below.

The handle portion 102 includes one or more actuation mechanisms thatcontrol functions of the device 100. For example, the trigger 106 andassociated mechanisms within the handle portion 102 can control a vacuumsystem either in the device 100 or remotely coupled to the device, andthe lever 108 and associated mechanisms within the handle portion cancontrol suture clip deployment, suture cutting, and/or advancement ofremaining suture clips loaded on the device 100.

As shown in FIGS. 18A-18F, the shaft portion 104 can comprise a mainshaft or hypotube 120, a vacuum tube 122, a clip plow or pusher 126, oneor more clips 130, an outer tube 132, a clip guide 138, a knife tube140, a suture door 152, and/or other components. The shaft portion 104is also shown assembled in FIGS. 23A-23F.

The hypotube 120 can be a tubular shaft having an inner lumen withdistal opening, as shown in FIG. 18B. The clips 130 are mounted in axialalignment on the outer surface of a distal end portion of hypotube 120,as shown in FIG. 18C. The device can be configured to be loaded with anynumber of clips 130, such as up to 10 or 15 clips. As shown in FIG. 18B,the vacuum tube 122 can comprise a vacuum chamber 124 at a distal end.The vacuum chamber 124 is partially open on an upper side to expose alumen within the vacuum tube 122. A cross-sectional view of the vacuumchamber 124 and adjacent components is shown in FIGS. 23C and 23D. Adistal end of the vacuum chamber 124 is attached to a proximal end ofthe hypotube 120 such that an inner lumen of the hypotube is in fluidcommunication with the inner lumen of the vacuum chamber 122 and theopen portion at the vacuum chamber 124. The suture door 152 can coverthe vacuum chamber 124 to close off the opening and the inner lumen whena vacuum is applied to the inner lumen, as described below. When thesuture door 152 is open, one or more sutures 131 drawn through the innerlumen from the distal opening of the hypotube 120 can be drawn outlaterally from the inner lumen through the opening in the vacuum chamber124, as shown in FIG. 17B.

The clip plow 126 is positioned around the hypotube 120 and configuredto drive the clips 130 distally along the hypotube 120, as shown in FIG.23E. The hypotube 120 passes between two split distal portions 166 ofthe clip plow, as shown in FIG. 18B, which are frictionally engaged withthe outer surface of the hypotube 120. This frictional engagement causesthe clip plow 126 to tend to move axially along with movement of thehypotube 120 via the actuation mechanisms in the handle portion 102unless the frictional engagement between the clip plow and the hypotubeis overcome by another axial force on the clip plow.

The clip plow 126 is positioned within the clip guide 138, as shown inFIGS. 18B and 23E. The clip guide 138 comprises a channel 160 in whichthe plow 126, the hypotube 120 and the clips 130 travel axially. Thechannel 160 can include a keyed geometry that corresponds to the shapeof a key portion 168 of the plow (see FIG. 18B) to maintain rotationalorientation. The channel 160 further comprises a plurality of grooves162 on either side of the channel that are spaced apart axially aboutthe length of one clips 130. The grooves 162 engage with prongs 164 atthe proximal end of the plow 126 to create a ratcheting mechanism thatallows the plow 126 to move distally relative to the guide 138 but notproximally. When the hypotube 120 and vacuum tube 122 are moved distallyby the actuation mechanism in the handle portion, the frictionalengagement between the plow 126 and the hypotube 120 pulls the plow 126distally. Because the prongs 164 have a sloped distal surface, theprongs 164 can flex inwardly and exit the grooves 162 of the guide 132in response to the distal friction force exerted on the plow 126 by thehypotube 120. When the prongs 164 disengage from the grooves 162, theplow 126 can be pulled distally along the guide 132 by the hypotubeuntil the prongs 164 reach the next pair of grooves 162 in the guide132, at which point the prongs 164 recoil outwardly into those grooves162. However, the prongs 164 can have blunt or otherwise not slopedproximal surfaces such that when the hypotube 120 is pulled proximally,the prongs 164 do not disengage from the grooves 162 and thereforprevent the plow 126 from moving proximally along with the hypotube 120.This breaks the frictional engagement between the plow 126 and thehypotube 120 and allows the hypotube to move proximally relative to theplow 126. In so doing, the plow 126 prevents the clips 130 from movingproximally along the hypotube 120 as the most proximal of the clips 130abuts the distal end of the plow 126. This breaks the frictionalengagement between the clips 130 and the hypotube 120 and allows thehypotube to also move proximally relative to the clips 130. In so doing,as distal end of the hypotube 120 can slide proximally out from withinthe most distal clip 130, allowing that clip to resiliently returntoward its natural crimped configuration and become secured onto one ormore sutures 131 inserted into lumen of the hypotube 120, as shown inFIG. 17A. The number of pairs of grooves 162 in the clip guide 132 cancorrelate to the maximum number of clips 130 that can be loaded into thedevice 100. The device 100 is shown fully loaded with clips 130 in FIGS.23C-23F, with the prongs 164 positioned in the most proximal pair ofgrooves 162. The plow 126 can ratchet forward along the guide 132 oneclip length after each clip 130 is deployed. The vacuum tube 122, plow126, hypotube 120, and clip guide 138 can all be fixed rotationally suchthat they maintain a fixed rotational alignment to one another and tothe handle portion 102.

The outer tube 132 can be positioned around the vacuum tube 122 and theclip guide 138. A proximal end of the outer tube 132 can be fixed to thehandle portion 102 via the adapter 136 (see FIGS. 24 and 25) such thatthe outer tube 132 does not rotate or translate relative to the handleportion. The outer tube 132 can comprise a lateral opening 134 that isaxially aligned with the opening in the vacuum chamber 124 to allowaccess to the inner lumen to draw out the free end of the suture, asshown in FIG. 17B.

As shown in FIGS. 18E and 18F, the shaft portion 104 can also include aknife portion 140 positioned around the outer tube 132. The knifeportion 140 also includes a lateral opening 142 that is axially alignedwith the opening in the vacuum chamber 124 to allow access to the innerlumen to draw out the free end of the suture. The knife portion 140 canalso comprise a cut-away distal end portion 144 and cutting blade 146positioned at the distal end and oriented perpendicular to thelongitudinal axis. When assembled, as shown in FIG. 17B, the blade 146is positioned just distal to the distal end of the outer tube 132 andthe distal end of the clip guide 138. The blade 146 can cover more than50% of the cross-sectional area of the knife portion 140 such that whenthe knife portion 140 rotates, the blade 146 shears across the distalend of the clip guide 138 can cuts any sutures passing into the innerlumen of the hypotube 120, the distal end of which can be located justproximal to the distal end of the clip guide 138. The knife portion 140can further comprise a slot 148 located near the proximal end of theknife portion. The slot 148 can engage with the actuation mechanism ofthe handle portion 102 to allow the knife portion to be rotated. Theadapter 150 can couple the proximal end of the knife portion 140 to thehandle portion 102 to prevent axial motion of the knife portion (asshown in FIGS. 24 and 25).

The longitudinal axis of the hypotube 120 can be offset upward from thelongitudinal axis shared by the vacuum tube 122, the outer tube 132, andthe knife portion 140. This allows the blade 146 to be positioned belowthe clips 130 and the suture when the knife portion is not actuated, andthen allows the blade 146 to rotate across the axis of the suture andhypotube when the knife portion is actuated.

The suture door 152 can be mounted around the knife portion 140 in orderto cover and uncover the vacuum chamber 124 and lateral openings 134 and142. The suture door 152 can be slidable along the outer surface of theknife portion 140, either manually or via mechanical actuation, toselectively open and close the lateral access to the inner lumen of thevacuum tube 122. When the suture door 152 in the closed position (e.g.,in FIG. 17A) a low pressure can be maintain in the inner lumen of thehypotube 120, allowing a suture 131 to be drawn into the distal openingof the hypotube. When the suture door 152 is moved to an open position(see FIG. 17B), the vacuum in the hypotube is reduced as air can bedrawn directly through the lateral openings 142, 134, through the vacuumchamber 124 and into the vacuum tube, bypassing the narrowing lumen ofthe hypotube. When the suture door 152 in the open position, a suture131 drawn through the hypotube can be manually accessed and drawnlaterally out through the lateral openings 134, 142, as shown in FIG.17B. This can allow a user to grasp the free end of the suture 131 andadjust the tension in the suture prior to deploying a clip 130 onto thesuture.

The handle portion 102 of the device 100 is shown in FIG. 17A(perspective view), FIGS. 19A-19C (exploded views), FIGS. 21-22 (sideand top views), FIGS. 23A-23B (cross-sectional top views), and FIGS.24-25 (cross-sectional side views). The handle portion 102 can comprisehousing portions 180 that enclose most of the actuation mechanisms,provide a hand grip, and mounting locations for some other components ofthe device 100.

In the illustrated embodiment, the proximal end of the vacuum tube 122is coupled to a vacuum hose adapter 184 mounted within the housing 180.A spring 188 is positioned around the vacuum hose adapter 184 andmounted within the housing such that the vacuum hose adapter 184 and thevacuum tube 122 can be actuated axially but prevented from rotating. Thevacuum hose adapter 184 is coupled to a vacuum hose 186, which can becoupled to an external vacuum source adapter 112 and/or be coupled to avacuum source included within the housing 180. A proximal end of thespring 188 abuts a collar stop 190 mounted in fixed position within thehousing. The vacuum hose adapter 184 passes through the collar stop 190and is fixed to a pivot collar 192. The pivot collar 192 includeslateral pins 198 that pivotally engage openings 196 at one end of links194. Openings 200 at opposite ends of links 194 pivotally engage pivotpins 202 that extend fixedly from an upper portion of the lever 108.Roller bearings 208 are rotatably attached to the ends of the pins 202outside of the links 194. The roller bearings 208 are positioned withinhorizontal slots 206 of plates 204, which are mounted to the housing180.

The lever 108 can include a lower extension that protrudes outside ofthe housing and provides a manual actuation location. An upper portionof the lever 108 adjacent to the pins 202 can comprise opening 212 thatis mounted around an intermediate portion of an anti-rotation pin 210via one or more roller bearings 216. The ends of the pivot pin 210 areslidably engaged in the notches 214 in the plates 104.

The lever 108 can further comprise a slot 234 to the rear of and belowthe opening 212. The slot 234 is mounted around a pin 232 that can slidetransversely along the slot. The pin 232 is rotatably engaged withopenings 230 at lower-rear end of respective links 226 on either side ofthe lever 108. The lateral ends of the pin 232 are slidably engaged viaroller bearings 238 within horizontal slots 236 in the plates 204.

Openings 228 in upper-front ends of the links 226 are pivotally coupledto pins 224 of a knife actuator 220, as shown in FIGS. 19C and 24. Thepins 224 are also slidably engaged in horizontal slots 225 (FIGS. 24,25) in the housing 180. The knife actuator 220 comprises a forwardcollar 222 positioned outside of the housing 180 and mounted around theknife portion 140 of the shaft assembly. The collar 222 includes avertical pin 223 that extends downwardly into the slot 148 in the knifeportion 140.

The vacuum trigger 106 can be mounted to the housing 180, such as viapivot axis 242 and spring arm 243, such that depressing the trigger 106mechanically and/or electrically controls the level of vacuum applied tothe vacuum tube 122. The vacuum trigger 106 can be used to initiallydraw a suture or sutures 131 into the hypotube and optionally outthrough the lateral openings 134, 142 to tension the suture as desired.When the suture 131 is tensioned as desired and ready to be secured witha clip, the vacuum trigger 106 can be released and the lever 108 can beactuated.

When the lever 108 is pulled rearwardly relative to the housing 180, thelever is initially prevented from pivoting due to the anti-pivot pin 210being constrained in the notches 214 of the plates 204. Thus, the lever108 is initially only allowed to translate rearwardly about the lengthof one clip 130. During this initial rearward translation, the pins 202slide rearwardly along substantially the entire length of the slots 206,which can be about the length of one clip 130. The pin 232 also movespartially along the horizontal slots 236 in the plates 204 but does nottranslate along the vertical slot 234 in the lever yet. This initialhorizontal translation of the lever 108 causes the links 194 to pull thevacuum hose adapter 184 rearwardly, compressing the spring 188, andcausing the vacuum tube 122 and hypotube 120 to also move proximallyabout the length of one clip 130. The clip plow is held still due to thepositive engagement of the prongs 164 in the notches 162, and thehypotube is pulled out from within the most distal clip 130, causing theclip to deploy off the hypotube and onto a suture.

Also during the initial horizontal translation of the lever 108, thelinks 226 move rearwardly and pull the knife trigger 220 rearwardlyabout the length of a clip 130. This causes the pin 223 in the collar222 to move proximally along an axial portion 170 of the slot 148 (seeFIG. 18E). As the pin 223 moves along the axial portion 170 of the slot148, the knife portion 140 is not caused to rotate. However, subsequentproximal movement of the pin 233 along the helical portion of the slot148 causes the knife portion 140 to rotate and cut the suture after aclip 130 is deployed.

The subsequent proximal movement of the pin 223 can be caused by furtherpulling of the lever 108. After the initial rearward translation, theanti-rotation pin 210 exits the notches 214 as is free to move upwardlyand rearwardly. This allows the lever 108 to begin to rotate about thepins 202 while the slots 206 prevent the lever from translating anyfurther rearwardly. As the lever pivots about the pins 202, the pin 232continues to translate rearwardly along the slots 236 of the plates 204and being translating along the slot 234 in the lever 108. As the pin232 translates further rearwardly, it pulls the links 226 furtherrearwardly, which pulls the knife trigger 220 further rearwardly,causing the pins 224 to slide rearwardly along the slots 226 and causingthe collar 222 and pin 223 to move further rearwardly, which rotates theknife portion 140, as discussed above.

After the knife portion 140 is sufficiently rotated to cut the suture131, the lever 108 can be released. A spring 240 can be attached betweenthe housing and the lever 108 (e.g., at the point 241) to cause thelever to rotate back to the point where the anti-rotation pin 210reaches the plates 204, and then the spring 188 can urge the lever 108to translate forward as the anti-rotation pin 210 re-enters the notches214 and the actuation process reverses itself.

As the lever translates forward, the vacuum tube 122 and hypotube 120move distally. The clip plow 126 and clips 130 also move distally thesame amount, about the length of one clip 130, and the prongs 164 moveup one notch in the clip guide 138 such that the next clip is ready tobe deployed the next time the lever is pulled.

In some embodiments, the device 100 can comprise a clip monitoringsystem that tracks/determines and displays the number of clips remainingloaded in the device. The device can comprise a display, such as a reardisplay 114 (see FIGS. 21-22), that shows how many clips remain. In someembodiments, when the last clip has been deployed, the clip monitoringsystem can cause the device to become locked such that lever 108 cannotbe pulled. In some embodiments, the clip monitoring system can alsodisplay a lock-out indicator on the display. The display can bemechanical or electronic, analog or digital.

In some embodiments, the device can comprise a suture tension monitoringsystem that includes a sensor to measure tension in the suture and adisplay, such as the display 114 or otherwise, that shows a tensionvalue, such as in pounds or Newtons.

In some embodiments, the device can comprise a vacuum monitoring systemthat determines and displays the pressure in the inner lumens and/or theamount or status of vacuum being generated or applied from a vacuumsource. In some embodiments, an indicator on a display can indicatesimply whether the vacuum is being applied, while in other embodiments,a level of vacuum or pressure can be displayed.

The embodiment shown in FIG. 25 includes an internal vacuum source 250mounted within the housing. The internal vacuum source 250 can be usedin lieu of an external vacuum source or as a secondary option to anexternal vacuum source. In some embodiments, the internal vacuum source250 can be coupled to the vacuum house adapter 184 that is separate fromthe hose 186 shown, and in other embodiments, a forked hose can be usedthe branches to both internal and external vacuum sources. A switch 252,shown in FIG. 25, can be used to switch between the external vacuumsource and the internal vacuum source 250. The internal vacuum source250 can be powered by a battery source housed within the handle portion102. If the battery dies, for example, the switch 252 can be used toswitch to an external vacuum source. Conversely, the user can switchfrom an external vacuum source to the battery powered internal vacuumsource 250. The battery can also power the monitoring systems anddisplays discussed above.

In some embodiments, the device 100 can be disposable after being usedduring a surgery and/or when all the loaded clips have been deployed. Inother embodiments, the device 100 can be cleaned and reloaded with clipsand reused. This can include moving the clip plow 126 back a moreproximal position in the clip guide 138.

FIG. 26 shows another exemplary suture clip deployment device 300. Thedevice 300 includes a handle 302, an outer tube 304, and an inner tube306. A suture clip 322 (which can comprise any of the clips disclosedherein or equivalents) can be loaded onto a distal end portion of theinner tube 306, which extends about one clip length past the distal endof the outer tube 304. A free end of a suture or sutures 334 can bethreaded through a lumen of the inner tube 306 and out through a lateralport 307, 308 that passes through both the inner tube 306 and the outertube 304. The lateral port can comprise a slot 307 in the sidewall ofthe inner tube 306 and a slot 308 in the sidewall of the outer tube 304that are aligned prior to actuation. A user can then grasp the free endof the suture 324 projecting out from the lateral port and apply adesired tension before deploying the clip 322 onto the suture.

An actuation mechanism 320 can then be manually actuated (e.g., pulledproximally) to cause the inner tube 306 to move proximally relative tothe loaded clip 322 in order to deploy the clip off the distal end ofthe inner tube 306 onto the suture 324. As the inner tube 306 movesproximally relative to the outer tube 304, the distal end of the outertube 304 can abut the clip 322 and force the clip to move distallyrelative to the retracting inner tube 306.

Further, as the inner tube 306 moves proximally relative to the outertube 304, the slot 308 in the outer tube move across the slot 307 in theinner tube and can thereby cut or shear off a free end of a suture 324that extends out through the port after that clip has been deployed ontothe suture. The slot 308 in the outer tube and/or the slot 307 in theinner tube can be sharpened to help cut the suture 324. In someembodiments, the distal end of the inner tube can be sharpened orinclude a blade to cut off the free end of the suture 324 just proximalto where the clip 322 is deployed onto the suture.

The handle 302 can have any configuration, such a gun handleconfiguration like the device 100. The handle 302 houses the actuator320 and optionally a spring to urge the actuator to return to theforward position after it is pulled rearward to deploy a clip 322. Thehandle 302 can further include various ports and/or displays, such asfor the systems described below.

In some embodiments, the device 300 can include a vacuum system fordrawing a suture into the inner tube, while the device 300 does notinclude a vacuum system in other embodiments. In embodiment including avacuum system, the device 300 can optionally include an internal vacuumsource and/or can include a connector for coupling the device to anexternal vacuum source.

In some embodiments, the device 300 can include a tension monitoringsystem, a clip monitoring system, a vacuum monitoring system, and/or adisplay similar to those described with regard to the device 100.

In some embodiments, the device 300 can include a lighting system. Thelighting system can comprise one or more light conductors, such asoptical fibers 310, that transfer light from a light source to near thedistal end of the outer tube 304. The light source can be external tothe device 300 or can be included in the handle 302 as part of thedevice 300. As shown in FIG. 26, the fibers 310 can extend through thehandle 302 and through an extension arm 311 to an adaptor 312 configuredto be coupled to an external light source 314. In some embodiments, thefibers 310 can be positioned between the inner tube 306 and the outertube 308, as shown in the cross-sectional view of FIG. 27. In otherembodiments, the light fibers can be positioned between the outer tube304 and another tube (not shown) surrounding the outer tube and thelight fibers in order to isolate the light fibers from the motionbetween the inner and outer tubes. The distal ends of the fibers 310 canprovide light near the clip deployment location within otherwise darkregions within the body to assist the user during the clip deploymentprocess. Some embodiments of the device 100 can similarly include such alighting system.

In some embodiments, the device 300 can include a visual monitoringsystem configured to capture visual information from the near the distalend of the outer tube 304 and transfer the captured visual informationto a proximal visual display. For example, the device 300 can include acamera or endoscope positioned near the distal end of the outer tube 304that is coupled via wiring to an adaptor 316 extending from the handle302 and configured to be coupled to an external monitor that a user canview to assist in the clip deployment process. Some embodiments of thedevice 100 can similarly include such a visual monitoring system aswell.

In view of the many possible embodiments to which the principles of thedisclosure may be applied, it should be recognized that the illustratedembodiments are only preferred examples and should not be taken aslimiting the scope of the disclosure. Rather, the scope of thedisclosure is defined by the following claims. We therefore claim allthat comes within the scope of the following claims.

We claim:
 1. A device for deploying a suture clip onto a suture,comprising: a proximal handle portion comprising an actuation mechanism;a generally tubular main shaft having an inner lumen, a proximal endportion coupled to the actuation mechanism, a distal end portion havinga distal opening in communication with the inner lumen, and anintermediate portion having a radial opening in communication with theinner lumen, wherein the main shaft is configured to hold one or moreannular suture clips loaded on the distal end portion of the main shaft,and wherein the main shaft is also configured to receive at least onesuture extending through the distal opening, through the inner lumen,and through the radial opening; and a pusher positioned at leastpartially around the main shaft and coupled to the actuation mechanismindependently of the main shaft, the pusher configured to be positionedproximal to the one or more suture clips when the one or more sutureclips are loaded on the main shaft; wherein the actuation mechanism isconfigured to cause the main shaft to move proximally relative to thehandle portion, the pusher, and the one or more suture clips loaded onthe main shaft, such that a distal-most one of the one or more sutureslips slides distally off of a distal end of the main shaft and onto asuture extending through the distal opening of the main shaft.
 2. Thedevice of claim 1, wherein the inner lumen of the main shaft is fluidlycouplable to a vacuum source that reduces pressure within the innerlumen such that a suture can be drawn into the inner lumen through thedistal opening of the main shaft.
 3. The device of claim 1, wherein thehandle portion comprises a vacuum source that is fluidly coupled theinner lumen of the main shaft to assist in drawing a suture through thedistal opening and into the inner lumen.
 4. The device of claim 2,wherein the handle portion further comprises a manual vacuum controllerthat controls the vacuum in the inner lumen.
 5. The device of claim 1,wherein the device is configured such that, after a suture clip isdeployed onto the suture, the actuation mechanism causes the main shaft,the pusher, and any suture clips remaining on the main shaft to movedistally together relative to the handle portion.
 6. The device of claim1, further comprising an outer shaft positioned around the main shaftand the pusher and coupled to the handle portion, the outer shaftcomprising a blade at a distal end portion that is configured to cut thesuture after the suture clip is deployed onto the suture, wherein thecutting of the suture occurs between the distal end of the main shaftand a proximal end of the deployed suture.
 7. The device of claim 6,wherein the actuation mechanism causes the outer shaft to rotaterelative to the main shaft and the handle portion, and wherein therotation of outer shaft causes the cutting of the suture.
 8. The deviceof claim 1, further comprising a cover member slidably mounted over theradial opening of the main shaft, the cover member being configured toselectively open and close the radial opening of the main shaft.
 9. Thedevice of claim 1, wherein the pusher comprises a ratcheting mechanismthat allows the pusher to slide distally relative to the main shaft butprevents the pusher from sliding proximally relative to the main shaft.10. The device of claim 1, wherein the device is configured to be loadedwith a plurality of suture clips that are deployable without reloadingthe device.
 11. The device of claim 1, further comprising a suturetension monitoring system configured to determine and display the amountof tension in a suture positioned within the inner lumen of the mainshaft.
 12. The device of claim 1, further comprising a suture clipmonitoring system configured to determine and display the number ofsuture clips that are currently loaded on the main shaft.
 13. The deviceof claim 1, further comprising a lighting system configured to providelight near the distal end of the main shaft.
 14. The device of claim 13,wherein the lighting system comprises one or more light fibers thatextend along the length of the main shaft and are configured to conductlight from a proximal light source to near the distal end of the mainshaft.
 15. The device of claim 1, further comprising a visual monitoringsystem configured to capture visual information from the near the distalend of the main shaft and transfer the captured visual information to aproximal visual display.
 16. The device of claim 1, wherein the one ormore suture clips are comprised of a shape-memory material, wherein theone or more suture clips are held in a resiliently deformed annularconfiguration when loaded onto the main shaft, and wherein the one ormore suture clips resiliently return toward a natural collapsedconfiguration when deployed onto the suture, thereby becomingfrictionally secured to the suture.
 17. A method for deploying a sutureclip onto a suture, comprising: causing a free end of at least onesuture to enter into a distal end portion of an inner lumen of a mainshaft of a suture clip deployment device; and causing the main shaft tomove proximally relative to a suture clip mounted around an outersurface of the main shaft such that the suture clip slides distally offof a distal end of the main shaft and onto the at least one suture suchthat the suture clip resiliently secures to the suture.
 18. The methodof claim 17, wherein causing a free end of at least one suture to enterinto the distal end portion of the inner lumen comprises reducing thepressure within the inner lumen in order to draw the free end of thesuture into the inner lumen.
 19. The method of claim 17, whereininserting a free end of the suture into the a distal end portion of theinner lumen comprises drawing the free end of the suture out of theinner lumen through a lateral opening in the main shaft.
 20. The methodof claim 19, further comprising applying tension to the free end of thesuture projecting from the lateral opening.
 21. The method of claim 17,further comprising causing a blade of the suture clip deployment deviceto cut off the free end of the suture after the suture clip is securedto the suture.
 22. The method of claim 21, further comprising, after thesuture is cut, causing the main shaft and suture clips remaining mountedon the main shaft to move distally relative to a handle portion of thesuture clip deployment device.
 23. The method of claim 22, furthercomprising, after the main shaft and suture clips remaining mounted onthe main shaft to move distally relative to a handle portion, repeatingthe steps of claim 17 to deploy another suture clip onto another suture.